System, Test, Anticardiolipin Immunological

FDA product code MID · 94 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5660
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1991-11-19 – 2024-12-17

MID 2024-12-17

Aptiva APS IgG Reagent; Aptiva APS IgM Reagent

Applicant Inova Diagnostics, Inc.

K number K223093

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MID 2013-12-23

ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY

Applicant Phadia US, Inc.

K number K131821

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MID 2013-10-21

BIOPLEX 2200 APLS IGM

Applicant Bio-Rad Laboratories

K number K130528

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MID 2013-02-26

QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA

Applicant Inova Diagnostics, Inc.

K number K120817

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MID 2012-10-25

IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS

Applicant Immco Diagnostics, Inc.

K number K113020

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MID 2012-03-30

BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS

Applicant Bio-Rad Laboratories

K number K103834

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MID 2011-12-12

ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K102425

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MID 2010-06-07

CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM

Applicant Phadia US, Inc.

K number K091845

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MID 2010-03-11

HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS

Applicant Instrumentation Laboratory CO

K number K092181

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MID 2006-02-07

EL-ACL SCREEN; EL-ACL IGM, IGG, IGA

Applicant Theratest Laboratories, Inc.

K number K060176

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MID 2004-05-12

AESKULISA CARDIOLIPIN AGM

Applicant Aesku, Inc.

K number K040463

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MID 2003-10-14

REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139

Applicant Corgenix, Inc.

K number K032868

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MID 2003-09-29

BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT

Applicant The Binding Site, Ltd.

K number K032240

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MID 2003-05-01

AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA

Applicant Hycor Biomedical , Ltd.

K number K030741

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MID 2003-01-03

REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT

Applicant Corgenix, Inc.

K number K024196

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MID 2003-01-03

MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT

Applicant Corgenix, Inc.

K number K024195

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MID 2002-11-13

VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896

Applicant Pharmacia Diagnostics GmbH & Co. KG

K number K023433

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MID 2002-09-25

REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001

Applicant Corgenix, Inc.

K number K022992

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MID 2002-09-25

REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001

Applicant Corgenix, Inc.

K number K022990

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MID 2002-08-27

APL IGA ELISA KIT

Applicant Louisville Apl Diagnostics, Inc.

K number K021398

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MID 2002-05-16

QACA IGG/IGM ELISA KIT HRP

Applicant Cheshire Diagnostics , Ltd.

K number K021192

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MID 2002-05-02

VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696

Applicant Pharmacia Deutschland GmbH

K number K020758

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MID 2002-05-02

VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796

Applicant Pharmacia Deutschland GmbH

K number K020757

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MID 2002-05-02

VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596

Applicant Pharmacia Deutschland GmbH

K number K020752

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MID 2002-03-13

QACA IGG/IGM ELISA KIT

Applicant Cheshire Diagnostics , Ltd.

K number K020241

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MID 2002-03-06

DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

Applicant Axis-Shield Diagnostics, Ltd.

K number K020156

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MID 2001-10-26

DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM

Applicant Diamedix Corp.

K number K012450

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MID 2001-10-26

DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

Applicant Diamedix Corp.

K number K012449

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MID 2001-09-20

REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT

Applicant Corgenix, Inc.

K number K013018

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MID 2001-08-23

MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT

Applicant Corgenix, Inc.

K number K012567

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MID 2001-08-20

DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM

Applicant Diamedix Corp.

K number K012053

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MID 2000-11-27

ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM

Applicant Quest Intl., Inc.

K number K003069

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MID 2000-08-21

DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500

Applicant Axis-Shield , Ltd.

K number K001981

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MID 2000-06-09

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

Applicant Axis-Shield

K number K001574

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MID 2000-04-26

REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT

Applicant Corgenix, Inc.

K number K000920

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MID 2000-02-01

AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA

Applicant Cogent Diagnotics , Ltd.

K number K993085

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MID 1999-11-24

AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA

Applicant Cogent Diagnotics , Ltd.

K number K992449

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MID 1999-09-21

AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA

Applicant Cogent Diagnotics , Ltd.

K number K992440

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MID 1999-03-18

ACL/APS FACS KIT

Applicant Louisville Apl Diagnostics, Inc.

K number K984102

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MID 1999-02-05

ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT

Applicant The Binding Site, Ltd.

K number K983696

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MID 1999-02-05

ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT

Applicant The Binding Site, Ltd.

K number K983695

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MID 1999-02-05

ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT

Applicant The Binding Site, Ltd.

K number K983694

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MID 1999-02-05

ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST

Applicant The Binding Site, Ltd.

K number K983692

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MID 1998-12-22

THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K984173

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MID 1998-12-17

THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F

Applicant Zeus Scientific, Inc.

K number K984347

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MID 1998-12-17

THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K984175

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MID 1998-06-02

ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K981021

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MID 1998-06-02

ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K981014

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MID 1998-05-18

ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K981020

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MID 1997-10-29

ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS

Applicant Zeus Scientific, Inc.

K number K973196

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MID 1997-07-23

ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K971784

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MID 1997-06-11

ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA

Applicant Immco Diagnostics, Inc.

K number K970177

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MID 1997-06-03

HEMAGEN ANTI CARDIOLIPIN SCREEN

Applicant Hemagen Diagnostics, Inc.

K number K971039

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MID 1996-10-10

ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY

Applicant American Laboratory Products Co., Ltd.

K number K962926

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MID 1996-09-09

ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY

Applicant American Laboratory Products Co., Ltd.

K number K962469

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MID 1996-05-30

DIASTAT ANTI-CARDIOLIPIN KIT

Applicant Shield Diagnostics, Ltd.

K number K955303

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MID 1996-05-23

ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY

Applicant American Laboratory Products Co., Ltd.

K number K955449

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MID 1996-02-09

CARDIOLIPIN IGG EIA TEST KIT

Applicant Immunoprobe, Inc.

K number K952523

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MID 1996-02-09

CARDIOLIPIN IGA EIA TEST SYSTEM

Applicant Immunoprobe, Inc.

K number K952522

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MID 1996-02-09

CARDIOLIPIN IGM EIA TEST SYSTEM

Applicant Immunoprobe, Inc.

K number K952521

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MID 1996-01-24

CARDIOLIPIN M EIA TEST SYSTEM

Applicant Hogan & Hartson

K number K946217

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MID 1996-01-24

CARDIOLIPIN A EIA TEST SYSTEM

Applicant Hogan & Hartson

K number K946216

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MID 1996-01-24

CARDIOLIPIN G EIA TEST SYSTEM

Applicant Hogan & Hartson

K number K946215

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MID 1995-12-18

REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT

Applicant Reaads Medical Products, Inc.

K number K952287

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MID 1995-10-13

CARDIOLIPIN IGG,M,A EIA TEST SYSTEM

Applicant Immunoprobe, Inc.

K number K951363

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MID 1995-10-02

VARELISA CARDIOLIPIN ABS SCREEN

Applicant Elias U.S.A., Inc.

K number K951187

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MID 1995-09-15

CARDIOLIPIN IGG,M,A EIA TEST KIT

Applicant Immunoprobe, Inc.

K number K952520

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MID 1995-09-01

QUANTA LITE IGA ACA (HRP)

Applicant Inova Diagnostics, Inc.

K number K953366

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MID 1995-08-29

QUANTA LITE ACA SCREEN (HRP)

Applicant Inova Diagnostics, Inc.

K number K953291

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MID 1995-07-18

QUANTA LITE ACA IGM (HRP)

Applicant Inova Diagnostics, Inc.

K number K946385

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MID 1995-07-18

QUANTA LITE(TM) IGG (HRP)

Applicant Inova Diagnostics, Inc.

K number K946034

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MID 1995-03-07

ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST

Applicant Immco Diagnostics, Inc.

K number K933788

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MID 1995-03-07

ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST

Applicant Immco Diagnostics, Inc.

K number K933786

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MID 1995-03-07

ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)

Applicant Immco Diagnostics, Inc.

K number K933784

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MID 1994-10-13

APHLELISA KIT

Applicant Louisville Apl Diagnostics, Inc.

K number K933588

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MID 1994-09-20

ELIAS CARDIOLIPIN ANTIBODIES

Applicant Elias U.S.A., Inc.

K number K940403

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MID 1994-06-30

HEMAGEN ACL IGA CALIBRATOR

Applicant Hemagen Diagnostics, Inc.

K number K941840

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MID 1994-01-24

SYNELISA CARDIOLIPIN ANTIBODIES

Applicant Elias U.S.A., Inc.

K number K935288

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MID 1993-12-08

ELIAS CARDIOLIPIN IGG ANTIBODIES

Applicant Elias U.S.A., Inc.

K number K933393

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MID 1993-12-08

ELIAS CARDIOLIPIN IGM ANTIBODIES

Applicant Elias U.S.A., Inc.

K number K933392

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MID 1993-07-16

HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0

Applicant Hemagen Diagnostics, Inc.

K number K932373

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MID 1993-07-06

ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K932225

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MID 1992-11-30

SYNELISA CARDIOLIPIN ANTIBODIES

Applicant Elias U.S.A., Inc.

K number K924421

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MID 1992-09-29

QUANTA LITE(TM) IGA ACA

Applicant Inova Diagnostics, Inc.

K number K922351

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MID 1992-09-28

QUANTA LITE ACA SCREEN

Applicant Inova Diagnostics, Inc.

K number K923320

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MID 1992-09-25

DIASTAT TOTAL ANTI-CARDIOLIPIN KIT

Applicant Shield Diagnostics, Ltd.

K number K923886

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MID 1992-08-20

IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST

Applicant General Biometrics, Inc.

K number K920401

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MID 1992-08-20

IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST

Applicant General Biometrics, Inc.

K number K920400

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MID 1992-08-03

DIASTAT ANTI-CARDIOLIPIN KIT

Applicant Shield Diagnostics, Ltd.

K number K921265

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MID 1992-06-04

SYNELISA CARDIOLIPIN ANTIBODIES

Applicant Elias U.S.A., Inc.

K number K921250

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MID 1991-12-18

READS(R) IGA ANTI-CARDIOLIPIN TEST KIT

Applicant Reads Medical Products, Inc.

K number K914405

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MID 1991-12-09

ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K911661

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MID 1991-11-27

3M ANTI-CARDIOLIPIN FAST(TM) TEST

Applicant 3M Diagnostic Systems, Inc.

K number K913054

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MID 1991-11-19

QUANTA LITE(TM) ACA

Applicant Inova Diagnostics, Inc.

K number K911680

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